Glycosylation of Exosomes in Prostate and Urothelial Carcinoma

Prostate Cancer Clinical Trial

Official title:

Glycosylation of Exosomes in Prostate and Urothelial Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04960956
• Other study ID #: IUSCC-0588
• Status: Terminated
• Start date: October 13, 2016
• Est. completion date: February 2, 2017

Study information

• Verified date: February 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect a urine sample from patients with prostate and urothelial (bladder) cancer and healthy volunteers who do not have cancer, so that researchers can perform studies on microcellular structures called exosomes that may eventually lead to a new type of urinary biomarker test for prostate and urothelial cancer.

Description:

This is a one-time participation, banking study of up to 40 subjects (10 prostate, 10 urothelial, 20 without cancer). Subjects must meet eligibility at the time of informed consent and will donate approx. 200mL of urine sample.

Primary Objective:

To develop alternative and efficient urinary exosome isolation and glycan analysis approaches for especially large glycan structures, including their isomers present at low levels, which will particularly enhance current analytical technology.

To provide further testing of the current microfluidic-based approaches developed to screen glycan samples which this additional specimen will provide to assess whether the current analytical techniques are robust enough to handle this type of sample with sufficient resolution and sensitivity for useful analytical information.

To compare alterations in exosome-derived glycans in adults with prostate and urothelial carcinoma in comparison with the exosome-derived glycans in age-matched healthy adults for assessment of findings to explore if the tools could be applied for future study toward a liquid biopsy test.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males = 18 years old at the time of informed consent

2. Ability to provide written informed consent and HIPAA authorization

3. Willingness to donate a fasting urine sample for research Patient Cohort

1. Histologically confirmed prostate or urothelial carcinoma

2. Localized disease

3. No neoadjuvant chemotherapy for disease Healthy Volunteer Cohort

1. Healthy volunteers must not have prostate or urothelial carcinoma

Exclusion Criteria:

1. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety

2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Prostate Cancer
• Urothelial Carcinoma

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of urine spermine in the diagnosis of prostate and urothelial cancer	xFresh urine will be collected for MALDI-TOF analysis to detect the concentration of exosome-derived glycans in the urine sample	Baseline (one-time point)